NCT02355106

Brief Summary

The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
Last Updated

May 22, 2019

Status Verified

December 1, 2017

Enrollment Period

4.3 years

First QC Date

January 27, 2015

Last Update Submit

May 21, 2019

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

  • Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.

    30 DAYS

Secondary Outcomes (2)

  • Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure.

    30 minutes

  • Outcome success

    30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Atrial flutter Ablation

Device: PolarStart System

Interventions

PolarStart SystemDEVICE

Atrial flutter Ablation

Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFl tachyarrhythmia, including atrial fibrillation (AF).
  • At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG) within 6 months prior to enrollment.
  • Subject has been diagnosed with symptomatic AFl
  • Subject is at least 18 and ≤75 years of age.
  • Subject is able and willing to give informed consent

You may not qualify if:

  • Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT did not conclusively rule out thrombus
  • Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration \>7 days).
  • Subject had any previous left atrial ablation.
  • Subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case of an isolated coronary bypass surgery performed more than three months prior to the procedure.
  • Subject has permanent pacemaker or defibrillator implant.
  • Subject has 2° type II, 3° degree atrioventricular (AV) block or left/right bundle branch block pattern
  • Subject has unstable angina pectoris.
  • Subject has history of previous myocardial infarction (MI) or percutaneous intervention during the last three months or planned in the next 3 months.
  • Subject has symptomatic carotid stenosis.
  • Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
  • Subject has any contraindication for oral anticoagulation.
  • Subject has any history of previous transient ischemic attack (TIA) or stroke.
  • Subject has known intra-cardiac thrombus formation.
  • Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).
  • Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OLV Hospital

Aalst, 9300, Belgium

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (1)

  • Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.

    PMID: 34196991DERIVED

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 21, 2019

Last Updated

May 22, 2019

Record last verified: 2017-12

Locations

NL(1)BE(1)